Transcript So What Are We Going to Learn?

Deborah A Wenger
Consultant
Training and Regulatory Compliance
Downingtown, PA
484-354-5577
[email protected]
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Identify the purpose of an SOP
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Identify the basic elements of the Basic SOP Writing
Cycle
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Examine SOP Drafting Techniques for SOPs
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Recognize the ten principle guidelines for writing SOPS
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Examine an SOP Format
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Drafting
Planning
Review & Release
SOP Change Cycle
Implement
Check Implementation
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1.
2.
3.
4.
5.
6.
7.
Develop a plan!
Determine title, purpose,
and scope
Find a sample and
template
Collect information
Draft the SOP
Conduct peer review
Get management
acceptance
8.
9.
10.
11.
12.
13.
Validate
Submit for approval
Provide training
Release 
Check Implementation
Revise as necessary
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Theseus Professional Services, LLC
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What information is needed?
Where will it come from?
Data collection methods
Collecting data
Time management
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“A picture is worth a thousand words.”
“A flowchart is worth a thousand procedures.”
So what is a flowchart?
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A method of graphically describing an existing process or
a proposed process by using simple symbols, lines, or
words to display pictorially the activities and sequence in
the process.
Source: Harrington, H.J., Business Process Improvement, McGraw-Hill, 1991
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Advantage:
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Many decisions and steps
Complex processes
Emergency/critical procedures
Disadvantage:
Minimal detail
 Effort to produce and maintain
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Remove animal
carcasses
Place carcasses in
plastic bag and
seal.
Is this BSL2?
Submit Health
Report by 10 AM
Yes
Double bag
See SOP 301
Reporting Animal
Health Problems
End removal of
animal carcasses
No
Spray before
exiting room
Place in
designated
refrigerator or
freezer
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Mind Map uses words, lines, colors, images, and even
sounds to stimulate the brain!
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Characteristics:
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Subject represented by a central image
Main themes of the subject radiate from the central
image as main branches
Minor themes linked to the main themes
Branches connected forming a nodal structure
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1 to 99
Protective
clothing &
Well venti
lated
g
go
Sp
Kle ornz
s
ay
7d
s
t
Mi x
ing
ens
,
ion
irat
ing
i
sp
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xi n
Record
ion
at
pir
Ex
Safety
Concentrate
om
Fr
Dis
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e
Tim
e xp
e&
dat
Re
Clid
Di
g
y
fet
a
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M i xi n
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ex
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CHEMICAL
MIXING &
DISPENSING
n
tio
Di
d
cor
Mi
a
pir
at
Qu
y
Safet
ox
sp
en
si n
g
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Grammar – Principles 1 to 5
Accuracy/Clarity – Principles 6 to 7
Format – Principles 8 to 10
Sticklers Unite!
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Use Simple Command Statements
Action Verb  Object  Supportive Information
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Begin with action verb
 Omit:
 Shall / You / Articles (except for clarity)
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Describe object of the verb
 Identify it precisely
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Complete step with supportive information
 Location
 Object modifier
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Simple Command Statements?
Y/N:
Load cages on 3-sided rack.
Y/N:
Put on protective clothing before entering animal
holding area.
Y/N:
Before and after leaving building wash hands.
Y/N:
The room shall remain locked when the receiving
clerk or other authorized personnel are not
presented.
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Keep Action Steps Simple
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Use short, precise sentences
Limit action verbs
Use language that provides direct commands and
avoids complex terms (readability factor)
Avoid hidden instructions
Keep steps free of explanatory information
Avoid vague pronouns
Use standard and consistent acronyms,
abbreviations, terms, and definitions
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Action Steps Simple?
Y/N:
Remove, shake, and stack clean cages.
Y/N:
Turn workstation blower on. Gauges should
measure flow.
Use: Cage Wash versus Cagewash?
Use: Disinfectant versus sterilant?
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Avoid the Passive Voice
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Weak method of expressing action
Comprehension best at beginning of sentence
Passive voice leads to doubt
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Passive Voice?
Y/N: Soiled disposable garments will be discarded for next
entry.
Y/N: The HEPA vacuum will not be used on the dirty side of
the facility.
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Use Parallel Structure
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Write headings and words using the same tense,
ending, or other value
Quickly helps users read and comprehend
Fit steps to a pattern
Fit steps to a pattern
Examples
1. Remove cage from rack.
2. Place caging in workstation.
Trafficking involves reading procedures and the observation of posters.
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State Condition First
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Use conditional action steps to make a decision
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Write conditional statement first, followed by the
action
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if, then, when, or, and
If pH is below 6 or above 10, then notify a supervisor
Use expected and unexpected conditional steps
Separate multiple conditions from instructions
Emphasize conditional words
Use positive statements
Avoid using and and or in the same statement
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Condition Stated First?
Y/N: Disposable clothing may be saved at housing area exits if
not soiled for next entry.
Y/N: When going between animal holding areas and before
and after leaving building wash hands.
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Identify the Responsible Person
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Address procedure to primary user
Identify who is responsible for what
Use job titles consistently
Visually emphasize tasks and responsible
performer
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Use Quantitative Information
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Specify quantitative rather than qualitative
Use standard units of measure
Provide a well defined range of measurement
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List Multiple Objects
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Single verb followed by several objects
Verify the temperature, pressure, and pH level
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List in a vertical format (bullets, dashes, asterisks)
Number only to indicate order of performance
List three or more objects of a verb
Sample sentinel cage 1, 3, and 5
Use charts and matrixes to present a series of
objects
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Emphasize Important Information
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Information which if overlooked or misinterpreted
could result in user error or injury:
Warnings alert users to potential hazards to personnel or
animals
Cautions alert users to potential hazards to products or
equipment
Alerts advise users of important information when
neither danger to individual or equipment is involved
Notes call attention to important supplement information
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Use short, concise statements
Do not include action steps
Position before or on same page as step(s) that
apply
Remember an SOP is not a training manual
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WARNING
WEAR RUBBER GLOVES AND FACE
SHIELD OR GOGGLES WHEN MIXING
CLIDOX
CAUTION
CHARGE BATTERIES IN A WELL
VENTILATED AREA
ALERT
Do Not Change Switch Unless Power Is Off –
Equipment Settings May Be Lost
NOTE
No smoking allowed within 50 feet of building
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APPLICATION:
EMPHASIS
TECHNIQUE:
WARNING
Boxed,
centered,
bold type,
all caps
CAUTION &
NOTES
Boxed,
centered,
bold type,
initial caps
LISTS
Bulleted
LOGIC
STEPS
Indented
REFERENCES
Initial caps
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Use Referencing and Branching Appropriately
 Information already exists or is in another SOP
 So what is referencing and branching?
Referencing directs users to other steps or sections within
the procedure, or to other procedures, and then back to
the initial point
Branching routes users to other steps or sections within
the procedure, or to other procedures, but the user does
not return to the initial departure point
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Use Referencing and Branching Appropriately
User errors
 Overlook warnings, cautions, and notes
 Lose track of exit and entry points
 Get into endless loops
 Work becomes hard to track
 Rely on memory
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Use Referencing and Branching Appropriately
Guidelines
 For two or three steps, repeat steps
 Cite your source
 Point user to important information (warnings,
cautions, prerequisites, etc.)
 Make it clear where the return point is or what steps
can be skipped
 Avoid unnecessarily going forward or backward
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Use Referencing and Branching Appropriately
Reference wording
 …using SOP 110, Procuring Animals
 …in accordance with manufacturer’s instructions
 Refer to SOP 160, Cage Wash Operations
 Record results on Attachment 1, Census Report
Branch verbs
 Go to / Proceed to / Return to / Repeat
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Grammar
1.
Use Simple Command Statements
2.
Keep Action Steps Simple
3.
Avoid the Passive Voice
4.
Use Parallel Structure
5.
State the Condition First
Accuracy/Clarity
6.
Identify the Responsible Person
7.
Use Quantitative Information
Format
8.
List Multiple Objects
9.
Emphasize Important Information
10.
Use Referencing and Branching Appropriately
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Theseus Professional Services, LLC
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Assures tasks are done properly
Consistent structure for all facility documents
Easy for user to use
Easy to write other SOPs
Easy to review and approve (process followed)
Identifies important information
Provides level of confidence to outside examiners
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Header
Body
Footer
After 1st page?
Watch for white space!
Needed?
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Organization
 Animal Care
International
Approved by:
Title
Special Procedures During
Gestation and Weaning of
Rodents
SOP 24G-104
Rev. 0
(# vs. letter)
Effective Date:
June 8, 2003
Date:
Page 1 of 2
Optional
Footer
Reference Only When Printed – Destroy After Use (or)
Only Use on Date Printed – Last printed 10/10/2003 8:31 AM
Form Number
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1.
I. Introduction
2.
3.
6.
Precautions and Limitations
Terms, Definitions, Acronyms,
Abbreviations, and References
Responsibilities
7.
Performance Section
8.
Post Performance Activity
4.
II. Prerequisites
III. Work
IV. Post-Work
V. Results
VI. Support
Purpose
Scope
Applicability
5.
Test
Restoration
10.
Results
Records
11.
Appendixes and Attachments
9.
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Style
6.0
6.1
6.2
7.0
Quarantine Sanitation
Spacing
Equipment and Supplies
6.1.1 Wipe down all equipment and supplies
with a sterilant
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6.1.2 Do not reuse cleaning equipment (e.g., mop
heads, sponges, etc.) after wiped down
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Floors and Flat Surfaces
6.2.1 Disinfect floors and flat surfaces daily
Exit from Quarantine Area
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Writing SOPs That Work!
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